Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management (METABAR)
2026年6月8日 更新者：Betül Gülşen、Toros University
Evaluation of Postoperative Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms in Body Weight Management After Laparoscopic Sleeve Gastrectomy
This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment.
Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success.
In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed:
- Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels
- Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels
- Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS)
- Anthropometric measurements: body weight, height, waist and hip circumference, BMI
- Nutritional intake: 3-day dietary records
The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.
研究概览
详细说明
Obesity is defined by the World Health Organization (WHO) as abnormal or excessive fat accumulation that presents a risk to health. Bariatric surgery, particularly Laparoscopic Sleeve Gastrectomy (LSG), is considered the most effective long-term treatment for morbid obesity.
This prospective observational study will be conducted at Bursa Yıldırım Doruk Hospital with 40 volunteers who have undergone LSG within the last month. Participants will be evaluated at baseline (immediately after surgery) and at 6 months post-surgery.
Assessments include:
- Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated according to WHO criteria.
- Biochemical Parameters: Fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels will be obtained from patient records. Zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels will be analyzed using ELISA method (Biotek TS800) with commercial kits (RelAssay® Diagnostics, Ankara, Turkey) at Ankara Diagen Laboratory. Samples will be stored at -20°C until analysis.
- Gastrointestinal Symptom Rating Scale (GSRS): A validated 15-item scale assessing five dimensions: diarrhea, indigestion, constipation, abdominal pain, and reflux. Scores range from 1 (no discomfort) to 7 (very severe discomfort). Turkish validity and reliability was established by Turan and Asti (2011).
- Dietary Assessment: 3-day dietary records will be collected and analyzed using the Nutrition Information System (BeBIS) 8.2 software. Results will be evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).
Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 22.0. Normal distribution will be assessed using Kolmogorov-Smirnov/Shapiro-Wilk tests. Results will be expressed as mean ± standard deviation for continuous variables and frequency/percentage for categorical variables.
研究类型
观察性的
注册 (估计的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- 电话号码：+903246253300
- 邮箱：dytozlemozpak@hotmail.com
研究联系人备份
- 姓名：Betül GÜLŞEN, Assoc. Prof.
- 电话号码：+903246253300
- 邮箱：betul.atalay@toros.edu.tr
学习地点
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Bursa
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Bursa、Bursa、土耳其（türkiye）、16310
- Bursa Yıldırım Doruk Hospital
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首席研究员：
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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副研究员：
- Doğukan Durak, Assoc. Prof.
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副研究员：
- Seher ŞEN, Asst. Prof.
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接触：
- Betül GÜLŞEN, Assoc. Prof.
- 电话号码：+903246253300
- 邮箱：betul.atalay@toros.edu.tr
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接触：
- Doğukan DURAK;, Assoc. Prof.
- 电话号码：+905327243733
- 邮箱：dogukandurak404@hotmail.com
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首席研究员：
- Betül GÜLŞEN, Assoc. Prof.
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副研究员：
- Tuğçe Nur Doganay Yıldırım, MSc, RD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults with morbid obesity who underwent Laparoscopic Sleeve Gastrectomy (LSG) at Bursa Yıldırım Doruk Hospital General Surgery Clinic within the last month, meeting the inclusion criteria.
描述
Inclusion Criteria:
- Underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last 1 month
- Aged between 19-50 years
- BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities
- Signed informed consent form
- Non-smoker and non-alcohol dependent
Exclusion Criteria:
- Did not undergo or is not planned to undergo LSG
- Outside the age range of 19-50 years
- Did not sign the informed consent form
- BMI <40 kg/m² or BMI <35 kg/m² without obesity-related comorbidities
- Smoker or alcohol dependent
- Has an inflammatory disease
- Currently using probiotics, antibiotics, or fiber supplements
- Has a psychiatric disorder
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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LSG Group
Adults aged 19-50 years who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital.
Participants will be evaluated at baseline and 6 months after surgery for metabolic parameters, intestinal permeability markers, gastrointestinal symptoms, anthropometric measurements, and dietary intake.
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Participants will undergo two assessment visits: at baseline (within 1 month post-surgery) and at 6-month follow-up.
Each visit includes anthropometric measurements (body weight, height, waist and hip circumference, BMI), biochemical blood analysis (fasting glucose, lipid profile, insulin, zonulin, secretory IgA, LPS), gastrointestinal symptom evaluation via GSRS, and 3-day dietary records.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Fasting Blood Glucose Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Total Cholesterol Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Triglyceride Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in HDL Cholesterol Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in LDL Cholesterol Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in VLDL Cholesterol Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Fasting Insulin Concentration (µIU/mL)
大体时间：Baseline and 6 months
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Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Serum Zonulin Concentration (ng/mL)
大体时间：Baseline and 6 months
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Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Serum Secretory IgA Concentration (mg/dL)
大体时间：Baseline and 6 months
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Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
|
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Change in Serum LPS Concentration (EU/mL)
大体时间：Baseline and 6 months
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Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7)
大体时间：Baseline and 6 months
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Change in total score of the Gastrointestinal Symptom Rating Scale (GSRS) between baseline and 6-month follow-up.
The scale consists of 15 items across 5 subscales; scores range from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms.
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Baseline and 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Body Weight (kg)
大体时间：Baseline and 6 months
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Change in body weight between baseline and 6-month follow-up.
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Baseline and 6 months
|
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Change in Body Mass Index (kg/m²)
大体时间：Baseline and 6 months
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Change in BMI between baseline and 6-month follow-up.
Weight and height will be combined to report BMI in kg/m².
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Baseline and 6 months
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Change in Waist Circumference (cm)
大体时间：Baseline and 6 months
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Change in waist circumference between baseline and 6-month follow-up.
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Baseline and 6 months
|
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Change in Hip Circumference (cm)
大体时间：Baseline and 6 months
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Change in hip circumference between baseline and 6-month follow-up.
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Baseline and 6 months
|
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Change in Waist-to-Hip Ratio
大体时间：Baseline and 6 months
|
Change in waist-to-hip ratio between baseline and 6-month follow-up.
Waist and hip circumference measurements will be combined to calculate the waist-to-hip ratio.
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Baseline and 6 months
|
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Change in Daily Energy Intake (kcal/day)
大体时间：Baseline and 6 months
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Change in daily energy intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
|
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Change in Daily Protein Intake (g/day)
大体时间：Baseline and 6 months
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Change in daily protein intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
|
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Change in Daily Carbohydrate Intake (g/day)
大体时间：Baseline and 6 months
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Change in daily carbohydrate intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
|
Baseline and 6 months
|
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Change in Daily Fat Intake (g/day)
大体时间：Baseline and 6 months
|
Change in daily fat intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Betül GÜLŞEN, Assoc. Prof.、Toros University
- 学习椅：Özlem ÖZPAK AKKUŞ, Assoc. Prof.、Toros University
- 研究主任：Doğukan DURAK, Assoc. Prof.、Bursa Yıldırım Doruk Hospital, General Surgery Clinic
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.
- Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13.
- Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20.
- Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7.
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- Turan N, Ast TA, Kaya N. Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale. Gastroenterol Nurs. 2017 Jan/Feb;40(1):47-55. doi: 10.1097/SGA.0000000000000177.
- Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Debedat J, Clement K, Aron-Wisnewsky J. Gut Microbiota Dysbiosis in Human Obesity: Impact of Bariatric Surgery. Curr Obes Rep. 2019 Sep;8(3):229-242. doi: 10.1007/s13679-019-00351-3.
- Khanna S, Tosh PK. A clinician's primer on the role of the microbiome in human health and disease. Mayo Clin Proc. 2014 Jan;89(1):107-14. doi: 10.1016/j.mayocp.2013.10.011.
- Kalarchian MA, King WC, Devlin MJ, White GE, Marcus MD, Garcia L, Yanovski SZ, Mitchell JE. Surgery-related gastrointestinal symptoms in a prospective study of bariatric surgery patients: 3-year follow-up. Surg Obes Relat Dis. 2017 Sep;13(9):1562-1571. doi: 10.1016/j.soard.2017.03.028. Epub 2017 Apr 4.
- Poves I, Cabrera M, Maristany C, Coma A, Ballesta-Lopez C. Gastrointestinal quality of life after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006 Jan;16(1):19-23. doi: 10.1381/096089206775222032.
- Pekcan G, Şanlıer N, Baş M, Acar Tek N, Gökmen Özel H. Türkiye Beslenme Rehberi (TÜBER) 2022. Ankara: Hazar Reklamcılık; 2022.
- Beslenme Bilgi Sistemleri Paket Programı (BeBIS 8.2). İstanbul: Software NDB; 2015.
- Merdol TK. Toplu Beslenme Yapılan Kurumlar için Standart Yemek Tarifleri. Hatipoğlu Yayınları; 2003.
- Rakıcıoğlu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotoğraf Kataloğu Ölçü ve Miktarlar. Nadir Kitap; 2012.
- Pekcan G. Beslenme durumunun saptanması. Diyet El Kitabı. Ankara: Hatipoğlu Yayınevi; 2013:67-142.
- Kuyucu A. Bariatrik cerrahi uygulanmış hastaların ameliyat sonrası altı ay ve üzeri sürede vücut ağırlığı kaybının, besin tüketim durumunun ve bazı biyokimyasal bulgularının belirlenmesi. Yüksek Lisans Tezi. Gaziantep: Hasan Kalyoncu Üniversitesi Sağlık Bilimleri Enstitüsü; 2018.
- Hornig M. The role of microbes and autoimmunity in the pathogenesis of neuropsychiatric illness. Curr Opin Rheumatol. 2013 Jul;25(4):488-795. doi: 10.1097/BOR.0b013e32836208de.
- Davey KJ, O'Mahony SM, Schellekens H, O'Sullivan O, Bienenstock J, Cotter PD, Dinan TG, Cryan JF. Gender-dependent consequences of chronic olanzapine in the rat: effects on body weight, inflammatory, metabolic and microbiota parameters. Psychopharmacology (Berl). 2012 May;221(1):155-69. doi: 10.1007/s00213-011-2555-2. Epub 2012 Jan 11.
- Chen JC, Lee WJ, Tsou JJ, Liu TP, Tsai PL. Effect of probiotics on postoperative quality of gastric bypass surgeries: a prospective randomized trial. Surg Obes Relat Dis. 2016 Jan;12(1):57-61. doi: 10.1016/j.soard.2015.07.010. Epub 2015 Jul 18.
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- King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Elder KA, Flum DR, Hinojosa MW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ. Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity. JAMA. 2016 Apr 5;315(13):1362-71. doi: 10.1001/jama.2016.3010.
- Poole NA, Al Atar A, Kuhanendran D, Bidlake L, Fiennes A, McCluskey S, Nussey S, Bano G, Morgan JF. Compliance with surgical after-care following bariatric surgery for morbid obesity: a retrospective study. Obes Surg. 2005 Feb;15(2):261-5. doi: 10.1381/0960892053268499.
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- Monteforte MJ, Turkelson CM. Bariatric surgery for morbid obesity. Obes Surg. 2000 Oct;10(5):391-401. doi: 10.1381/096089200321594246.
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- Altunkaynak B, Özbek E. Obezite: Nedenleri ve tedavi seçenekleri. Dicle Tıp Dergisi 2007;34(2):144-149.
- Afshar S, Kelly SB, Seymour K, Woodcock S, Werner AD, Mathers JC. The Effects of Bariatric Procedures on Bowel Habit. Obes Surg. 2016 Oct;26(10):2348-54. doi: 10.1007/s11695-016-2100-9.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年5月20日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BCKLY-BGP-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to ethical considerations and participant confidentiality.
Data will be stored securely and used only for the purposes of this study in accordance with Turkish Personal Data Protection Law (KVKK) and the ethical approval pending from Toros University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.